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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Fiber Reactive Dyes Toxicological Profiles December 1981
Author:
U.S. Consumer Product Safety Commission
Year:
1981
Bibliographic source:
Fiber Reactive Dyes Toxicological Profiles December 1981,PB83-168732

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of Reactive ORANGE 4 in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name of the test chemical: 1,5-Naphthalenedisulfonic acid, 2-[2-[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)
Common Name: REACTIVE ORANGE 4
Molecular formula: C24H16Cl2N6O10S3.3Na
Molecular Weight: 781.473 g/mol
Substance Type:Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: 1,5-Naphthalenedisulfonic acid, 2-[2-[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)
Common Name: REACTIVE ORANGE 4
Molecular formula: C24H16Cl2N6O10S3.3Na
Molecular Weight: 781.473 g/mol
Substance Type:Organic
Physical State: Solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Other effects:
no data available

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No irritation effects were observed when Reactive Orange 4 was instilled into rabbit eyes.
Hence, Reactive Orange 4 can be considered to be not irritating to eyes.
Executive summary:

The ocular irritation potential of Reactive Orange 4 was assessed in rabbits.

Reactive Orange 4 was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration not mentioned).

No irritation effects were observed when Reactive Orange 4 was instilled into rabbit eyes.

Hence, Reactive Orange 4 can be considered to be not irritating to eyes.